AMI Lifesciences is Driven by Chemistry. Powered by People.
01 2Ami Lifesciences Private Limited
02 1Lee Pharma
03 1Shanghai Neutan Pharmaceutical
01 2MIROGABALIN BESYLATE
02 1MIROGABALIN BESYLATE (NEU1131-L)
03 1MIROGABALIN BESYLATE (PROCESS-II)
01 1China
02 3India
01 4Active
01 4Blank
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39342
Submission : 2023-12-29
Status : Active
Type : II
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41196
Submission : 2025-02-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38908
Submission : 2023-09-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40892
Submission : 2024-12-08
Status : Active
Type : II
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PharmaCompass offers a list of Mirogabalin Besylate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mirogabalin Besylate manufacturer or Mirogabalin Besylate supplier for your needs.
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PharmaCompass also assists you with knowing the Mirogabalin Besylate API Price utilized in the formulation of products. Mirogabalin Besylate API Price is not always fixed or binding as the Mirogabalin Besylate Price is obtained through a variety of data sources. The Mirogabalin Besylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mirogabalin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin, including repackagers and relabelers. The FDA regulates Mirogabalin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Mirogabalin supplier is an individual or a company that provides Mirogabalin active pharmaceutical ingredient (API) or Mirogabalin finished formulations upon request. The Mirogabalin suppliers may include Mirogabalin API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin DMFs exist exist since differing nations have different regulations, such as Mirogabalin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin USDMF includes data on Mirogabalin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin suppliers with USDMF on PharmaCompass.
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